Today the ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)’ was released.

It can be found: HERE

This Manual is not intended to replace other classification guidance documents, such as:

• • MDCG 2022-5 – Guidance on borderline between medical devices and medicinal products
  • MDCG 2021-24 – Guidance on classification of medical devices
  • MDCG 2020-16, Rev.1 – Guidance on classification for IVDs
  • MDCG 2019-11 – Qualification and classification of software

Instead, the Manual is intended to record the agreements reached by the Borderline and Classification Working Group (BCWG), following the exchanges under the Helsinki Procedure.

The Helsinki Procedure is a system ‘to allow consultation among competent authorities (CAs) on borderline and classification issues concerning medical devices and to ensure that appropriate guidance is published in the Manual on Borderline & Classification for Medical Devices…’

Below is an excerpt of a flowchart, to give a sense of the Helsinki Procedure process.

The Manual cites specific products assessed, under each relevant section. It covers borderline classifications between the MDR and IVDR, and to other legislation, such as: medicinal products, biocides, substances of human origin, cosmetic products, food, personal protective equipment, general consumer products and more.

As a result, some sections of the Manual may remain blank until an applicable borderline product is assessed within it. For example, the section ‘Borderline between medical devices and food’ has no entries at this time.

Borderline product decisions currently covered under the Manual include:

• • Nasal spray with antibodies for COVID-19
  • Product for professional removal of dental biofilm
  • Rescue bags for patient transport
  • Plexiglass box for caregiver protection
  • Smartphone application for STI prevention strategies
  • Classification of dermal fillers
  • Ethylene oxide gas cartridges

Casus will report as the Manual is updated over time.